Regulatory service

Regulatory Strategy
  • Complete Regulatory Strategy
  • Scientific Advice (formal, informal)
  • Negotiation with Regulators
Regulatory Operations
  • Submission
  • Tracking
  • Query management
  • Final approval
Scientific and Regulatory Writing

IBPS  also offers services in Scientific & Regulatory Writing. Drawing strongly from the fundamentals of “Proof of Details” our expert team of scientific writers provide high quality documentation compliant with ICH and regulatory requirements for your program. We also ensure timely delivery along with completeness of the documentation. We cover

  • CTD Dossier
  • IMPD for Phase1, 2, 3 studies
  • Investigator’s Brochure
  • Development Reports
  • Product Briefing Book for
    • Investment Purpose
    • Scientific Advice
  • Technical Presentation